Comparison of Provisional 1-Stent Strategy With Drug-Eluting Balloon Versus Planned 2-Stent Strategy in Patients With Non-LM Coronary True-Bifurcation Lesions (PROVISION-DEB).

Percutaneous coronary intervention (PCI) for bifurcation lesions presents several difficulties and often results in suboptimal procedural, postprocedural clinical outcomes. While the provisional 1-stent strategy is generally favored for its simplicity and favorable outcomes, a few studies suggest no significant difference between 1-stent and 2-stent techniques for true bifurcation lesions. Drug-eluting balloons (DEBs) have demonstrated potential in small vessel disease, including bifurcation side branches. However, no studies have compared the 2-stent strategy with the provisional 1-stent plus DEB strategy in non-LM true bifurcation lesions. Our study aims to address this gap by comparing these strategies, with a focus on real-world practice and detailed endpoint analysis. The PROVISION-DEB study is an open-label, randomized, multicenter clinical trial designed to investigate noninferiority and compare a 1-stent strategy with a drug-eluting balloon and a planned 2-stent strategy at non-LM coronary true-bifurcation lesions. A total of 750 patients with de novo non-LM coronary bifurcation lesions undergoing coronary interventions will be randomized 1:1 to either a provisional 1-stent plus DEB strategy or a 2-stent strategy with stratified Diabetes. The primary endpoint is a target lesion failure, composite outcome of cardiac death, target vessel myocardial infarction, or target lesion revascularization at the anticipated 3 years follow-up (6, 12, and 36 months). In conclusion, PROVISION-DEB study is a randomized, multicenter, noninferior clinical trial and will compare a 1-setnt strategy with a drug-eluting balloon and a planned 2-stent strategy at non-LM coronary true-bifurcation.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Sung-Ho her reports financial support was provided by Terumo Corportion. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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